InspireMD (NSPR) investor relations material

Executive summary

• Q1 2026 revenue reached $3.4 million, up 122% year-over-year, driven by strong global demand for CGuard Prime in the U.S. and original CGuard internationally.

• Over 625 cumulative carotid procedures using CGuard Prime performed across 100+ U.S. hospitals since launch.

• Net loss widened to $13.7 million from $11.2 million year-over-year, primarily due to higher operating expenses.

• Gross margin improved to 20.2% from 19.1% year-over-year, aided by favorable sales mix but offset by inventory impairment.

• Voluntary recall of the CGuard Prime 135 cm delivery system in the U.S. was initiated for technical enhancements; TCAR program unaffected.

Financial highlights

• Q1 2026 revenue was $3.4 million, a 122% increase from $1.5 million in Q1 2025.

• U.S. revenue was $1.2 million, up 36% sequentially from Q4 2025; international revenue was $2.2 million, up 48% year-over-year.

• Gross profit was $0.7 million (20.2% margin), up from $0.3 million (19.1%) in Q1 2025; adjusted gross profit (excluding impairment) was $1.2 million (34.1% margin).

• Operating expenses rose to $14.7 million from $11.8 million year-over-year, mainly due to U.S. commercialization investments.

• Cash and equivalents were $11.4 million as of March 31, 2026; marketable securities totaled $30.2 million.

Outlook and guidance

• Full-year 2026 revenue guidance was withdrawn due to the temporary U.S. commercialization pause.

• FDA approval for the original CGuard delivery system is anticipated in Q3 2026, enabling U.S. relaunch.

• FDA approval for CGuard Prime 80 cm for TCAR procedures is expected in the second half of 2026, potentially doubling the U.S. addressable market.

• Management expects continued losses and negative cash flows until commercial revenue scales to cover operations.

• Substantial doubt exists about the ability to continue as a going concern without additional financing.